The following data is part of a premarket notification filed by Southern Dental Industries, Ltd. with the FDA for Rok.
| Device ID | K012529 |
| 510k Number | K012529 |
| Device Name: | ROK |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3685001001 | K012529 | 000 |
| DO3685000111 | K012529 | 000 |
| DO3685000071 | K012529 | 000 |
| DO3685000061 | K012529 | 000 |
| DO3685000041 | K012529 | 000 |
| DO3685000031 | K012529 | 000 |
| DO3685000021 | K012529 | 000 |